Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy

Summary

The investigators aim to compare the risk of mortality of Non-implantable carioverter defibrillator (ICD) vs. ICD management in patients with heart failure with reduced ejection fraction (HFrEF).

Eligibility

Inclusion Criteria:

* Age ≥ 18 years (no upper limit)
* Class I or IIa indication for a primary prevention ICD15: Ischemic or non-ischemic cardiomyopathy and NYHA Class ≥ II if most recent LVEF is ≤ 35% OR ischemic cardiomyopathy with NYHA Class I if most recent LVEF is ≤ 30%
* Most recent LVEF (%) obtained per cardiac imaging obtained at any time prior to enrollment after being stable on optimal GDMT\*\* for at least one month
* Stable optimal GDMT at least one calendar month prior to last cardiac imaging test, prespecified as one of the following for at least 1 calendar month prior to study randomization:

receiving all 4 therapy classes (beta-blockers, ARNI/ARB/ACE, MRA and SGLT2i) OR GDMT Score ≥ 6 (per Figure 7)

• MADIT-ICD Benefit Score \< 50 (per Figure 4)

Exclusion Criteria:

* Existing ICD/CRT-D
* • Planned CRT-P or CRT-D implant for any indications including Class I or IIa indication for CRT: Presence of left bundle branch block (LBBB) with QRS ≥ 120 msec OR QRS duration ≥ 150 msec regardless of QRS morphology OR decision for CRT implant by EP provider for other indications
* Acute MI within the past 3 calendar months
* Chronic renal failure requiring hemodialysis
* Coronary revascularization within the past 3 calendar months
* History of sustained VT or VF
* Known genetic cause of cardiomyopathy
* Life expectancy \< 1 year
* Unable or unwilling to follow study protocol
* Inability to consent

Conditions2

Locations13 sites

Browse More Trials